TMF Plus and eCTD Plus 2018

Topics

• Industry best practices and their use and adoption
• The purpose and value of documents, files and data as assets in a drug development program
• The complete life cycle of regulatory content
• Paper and digital formats and understand transitioning from paper
• The benefit and challenges of partnering with CROs and FSPs
• Best Practices for Essential Documents in their handling and storage
• How regulations govern the repositories that retain Essential Documents
• Common models, including metrics, to demonstrate oversight of partners
• The newly released regulations, guidelines, and industry best practices and gain an awareness of their impact
• The factors to assess in determining whether or not to retain a record
• The eCTD and the basic tools for eCTD implementation
• Knowledge of the CTD/eCTD and its propose and
• What constitutes a Submission Ready Document
• Knowledge of the tools (software process) utilized before, during, after eCTD publishing
• Various Standard Operating Procedures recommended for an organization to perform compliant eCTD publishing processes
• The various tools associated with document/submission publishing and evaluating those tools against your companys needs while assuring regulatory compliance
• Outsourcing eCTD tasks and the associated benefits risks
• The various processes and best practices associated with quality regulated content management
• The newly released regulations, guidelines, and industry best practices and gain an awareness of their impact
• Your organization of the significant drivers impacting quality regulated content and document/submission publishing
• ECTD format submission mandates Regulatory agencies (US, EU, Canada, etc.)

Who should Attend

• Personnel involved in set up, maintenance, and auditing of the Trial Master File
• Records Management Specialists at Sponsors, CROs, FSPs, Vendors, Clinical Sites
• Project and/or Clinical Trial Assistants
• Project and/or Study Managers
• Clinical Research Monitors
• Clinical Operations Administrators
• Compliance Auditors
• Quality Assurance Personnel
• Consultants working in the life science industry involved in managing regulated content